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U.S. Department of Health and Human Services

Class 2 Device Recall SPINE INTERBODY FUSION SYSTEM

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 Class 2 Recall
SPINE INTERBODY FUSION SYSTEM
see related information
Date Posted May 27, 2013
Recall Status1 Terminated on March 26, 2014
Recall Number Z-1417-2013
Recall Event ID 64586
Premarket Notification
510(K) Number
K090064 
Product Classification Intervertebral Fusion Device With Bone Graft, Lumbar - Product Code MAX
Product Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead IBFD, Large Neutral, 9mm Copperhead IBFD, Large Neutral, 10mm Copperhead IBFD, Large Neutral, 11mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Code Information Item # C5006 C5007 C5008 C5009 C5010 C5011
Recalling Firm/
Manufacturer
Spinal Solutions, LLC
26157 Jefferson Ave
Murrieta, California 92562-9561
Manufacturer Reason
for Recall
The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
FDA Determined
Cause 2
DESIGN: Labeling Design
Action Spinal Solutions sent a recall letter dated March 8, 2013 to all customers who purchased loaner bins and sterilization trays for implants and instruments from Spinal Solutions. The letter identified the affected product, problem identified and actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
Quantity in Commerce 24 units
Distribution USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MAX and Original Applicant = EMINENT SPINE
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